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Introduction

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Human Subjects Research at EPA

Research with human subjects entails an intrinsic conflict for investigators. The goal of research is to make contributions to generalized knowledge, for example improving the understanding of a disease process or determining the efficacy of an intervention. The pursuit of this goal may involve activities with the potential to compromise the interests of individual participants in the research.

Ethical analysis is required to resolve this conflict when it occurs. The regulations, policies, and guidance governing human research are derived from such analyses.